rejuvenation with light-based home devices: a new … · device compared to a competitor home-use...

$: Rejuvenation with light-based home devices: a new … · device compared to a competitor home-use laser device ... another fractional home-use laser on my inner arm ... PPT Rejuvenation$
10/02/2013

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Rejuvenation with light-based home devices: a new option?

IMCAS

Paris, 31st January – 3rd February 2013

Godfrey Town, Innovation Scholar, University of Wales, Faculty of Applied Design & Engineering, Swansea Metropolitan University, Swansea, SA1 6ED, UK Eleanor Dyke, School of Engineering, Swansea University, Swansea, SA2 8PP, UK Kim Thorne, CyDen Institute of Light Therapy, Institute of Life Sciences, Swansea University, SA2 8PP, UK

Statement of Disclosure

Kim Thorne Kim Thorne receives salary from CyDen Ltd., SA1 8PJ, UK.

Eleanor Dyke Eleanor Dyke has no disclosures.

Godfrey Town Godfrey Town receives travel expenses and salary from CyDen Ltd., UK; Salary and equity position with GCG Healthcare Ltd., UK; Consulting fees from Unilever, USA. He is a committee member of TC76 WG4 and TC61 WG30.

This work is presented thanks to the support of CyDen Ltd., Swansea, UK

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Objectives:

The aims of this study were to: •  assess the relative comfort in-use of a home-use IPL

device compared to a competitor home-use laser device

•  examine the erythema side effect profile of IPL and laser home-use rejuvenation devices

•  comment on efficacy grading.

Materials and Methods: •  45 eligible female subjects completed one IPL treatment

on one side of their face and one laser treatment on the other side of their face

•  Treatment areas included peri-orbital area and full cheek.

•  Devices used according to manufacturer’s instructions.

•  Discomfort in-use was assessed at specific intervals by the subjects recording a discomfort / pain score on a Visual Analogue Scale (VAS).

•  Sensations experienced, any redness observed and the smoothness of the area were recorded on a self-assessment questionnaire at 120 minutes post-treatment.

•  Hemi-facial images were taken at specific intervals and a trained assessor blind-graded the test sites for erythema.

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Home-Use Rejuvenation Lasers

Philips ReAura: 1.2 W, 1435 nm, spot size 1.963×10-7cm2

Palomar PaloVia: max energy 15 mJ, wavelength 1410 nm, pulse

duration 10 ms, beam divergence 0.15, 9x6 grid = 54 pulses,

repetition rate15.4 Hz)

Home-Use Rejuvenation Lasers

Tria Beauty, Tria Laser

Intenzity Innovation Inc Laser: Power 900 mW, wavelength 1425 nm, spot size 100 μm, power density at skin surface 10 kW.cm2, fluence 50 J/am2 at 5 mJ/pulse; 70 J/am2 at 7 mJ/pulse; coverage per scan 5%. [Investigational device]

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Home-Use Rejuvenation IPL

iPulse prototype IPL: 7 J/cm2, pulse duration 19 ms (double pulse), wavelengths 525-1100 nm, spot size 3 cm2

Materials & Methods Two home use devices for skin rejuvenation were compared in this study for erythema response and comfort in-use - a novel IPL device and a representative home-use fractionated laser device. The home-use devices had the following specifications:

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Results: Pain Scores Scatterplot of subject-reported VAS scores for the IPL (x-axis) and laser (y-axis) for each subject (n = 45). VAS scale: 0 = no pain whatsoever; 100 = worst pain imaginable .

41 out of 45 subjects recorded higher VAS scores for the laser device than the IPL device post-treatment

Erythema Grading Examples

(Dykes PJ, Marks R. (1992). An evaluation of the irritancy potential of povidone iodine solutions: Comparison of subjective and objective assessment techniques. Clin Exp Derm, 17: 246-249).

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Results: Erythema Scores

Mean assessor-reported erythema scores at each time point for the IPL and laser devices using a published reference scale (Dykes PJ, Marks R. (1992). An evaluation of the irritancy potential of povidone iodine solutions: Comparison of subjective and objective assessment techniques. Clin Exp Derm, 17: 246-249).

Results: Erythema Scores

Mean subject-reported redness assessment at each time point for the IPL and laser devices. Analogue Scale: 0 = None. 1 = Slight, 2 = Definite

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Erythema (home-use

laser vs IPL)

Laser 15 minutes post

IPL 15 minutes post

Erythema (home-use

laser vs IPL)

IPL 120 minutes post


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Erythema (home-use

laser vs IPL)

IPL 360 minutes post


30 minutes post

24 hrs post

2 hours post 12 hours post

Personal experience of testing another fractional home-use

laser on my inner arm (edema, confluent erythema)

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Home Use Skin Rejuvenation (PaloVia)

Before and after 4 weeks of daily treatments Clinical photography courtesy of Dr C. Zachary, USA

Home Use Skin Rejuvenation (ReAura)

Clinical photography courtesy of Dr C. Zachary, USA

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Home Use Skin Rejuvenation (ReAura)

Clinical photography courtesy of Dr C. Zachary, USA

Patient Name: LJS 010 Age: 49

Visia Texture: 0.043932 – 60

Visia Wrinkles: 0.080199 – 54

Visia Spots: 0.030153 – 64

Visia UV Spots: 0.135968 – 47

Visia Brown Spots: 0.106549 – 40

Visia Texture Count: 1280

Visia Wrinkle Count: 38

Visia Spot Count: 104

Visia UV Spot Count: 464

Visia Brown Spot Count: 376

Before Tx

Home Use Skin Rejuvenation (at-home IPL)

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Patient Name: LJS 010 Age: 49



Visia Spots: 0.018637 – 85








After 3 Tx per week x 3 weeks + 9 weekly Tx


Before and after 3 Tx per week + 9 weekly Tx


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Patient Name: V-S 064 Age: 63



Visia Spots: 0.057357 – 27








Before Tx


Patient Name: V-S 064 Age: 63



Visia Spots: 0.047505 – 42









After 3 Tx per week x 3 weeks + 9 weekly Tx

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Before and after 3 Tx per week + 9 weekly Tx


Clinical Results:

•  The results of this study indicate that the IPL device caused significantly less pain / discomfort and erythema (p < 0.001 for both measures) than the laser device at each time point measured and for all time points combined.

•  This finding was also supported by the completed subject questionnaires, where specific references were made by subjects to the degree of pain felt using the laser device but not the IPL device.

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Conclusions: •  The IPL treatment was a well-tolerated, non-invasive, non-

ablative method for rejuvenating photoaged skin with minimal side effects, no downtime, no long-term sequelae, and a high measure of patient satisfaction when compared with the laser device tested in this study.

•  The fractionated laser caused a higher incidence of immediate erythema within this study, following a histamine reaction within the dermis.

•  Further comparative clinical studies are required to establish the extent of user acceptance of treatment-related side effects and tolerable discomfort associated with self-treatment.

•  Further studies are required to compare efficacy in reducing pigmentation, fine lines and wrinkles.

Standards & Regulatory Controls •  New IEC standards have been drafted: 60825-1 Ed/3 CDV and

60335-2-xx CD and are at voting / review stage by national committees.

•  Because skin changes are intended, GPSD guidelines may be insufficient for these consumer appliances (i.e. risk assessment by the manufacturer is required).

•  The MDD is being re-cast and will probably capture these products as OTC medical devices.

•  A few national GPSD committee representatives are pressing for an outright ban on home-use lasers and IPLs to restrict them to use by doctors only.

•  Given that other ‘directed energy’ products incl. electrolysis kits, high frequency skin cleansing, ultrasound, galvanic and radio frequency skin stimulation appliances all intentionally cause at least minor effects to the skin, perhaps a new MDD class of cosmetic medical devices needs to be considered?

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Thank you for your attention!

[email protected]

www.gcghealthcare.co.uk

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rejuvenation with light-based home devices: a new … · device compared to a competitor home-use...

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